FDA signals that nothing is ever “substantially equivalent”

by Carl V Phillips

The FDA Center for Tobacco Products (CTP) recently ruled on “Substantial Equivalence” (SE) applications about a group of smokeless tobacco products in the Ariva/Stonewall family. They ruled that these are not substantially equivalent to predicate products, which is an Orwellian way of saying they are banning them. In a week filled with bad news about supposedly health-oriented organizations threatening people’s health and welfare with anti-THR lies, this perhaps passed unnoticed by many. It should not have. It is by far the worst news of the week for Americans. We are still trying to make sense of the details as they relate to the particular products (note all the complexities below), but one implication is clear: FDA plans to use the SE process to block the introduction of THR products.

Some background: The Ariva/Stonewall products, developed by the firm Star Scientific are dissolveable smokeless tobacco lozenges — finely ground tobacco in a confectionery base. I mention this because a lot of people are not familiar. Despite being on the market for a long time, they have never sold well. Indeed, Star finally gave up on them, decided to get out of the business, and sold off the product line to a former employee, who continued to produce and sell them as a new company.

These are good products, and many who have discovered them quite like them (I cannot say that I do, but de gustibus non est disputandum). For various reasons, if we were about to be handed Divine Word on which smoke-free tobacco products are lowest risk, and bets were being taken, the smart money would be on these products. (Note that I pose the thought experiment in those terms because the risks of most other smoke-free tobacco products, while probably slightly higher, are basically the same – and basically all the same as abstinence – as far as we know or are likely to ever know. Since we do not know for sure and any difference is more than made up for by other preferences, it should be obvious that this is not an endorsement that satisfied vapers and users of other smokeless tobacco products should be trying to switch to Ariva.)

The ruling appears to not ban the original versions of these products. But seven new varieties, different flavors, are banned. Perhaps the most notable moment for these products, until now, was that Star threw together an MRTP application for the original products in the early days of CTP. Because CTP was clearly incapable of fulfilling its mission (whether that is the right verb tense is a topic for another day), they desperately punted with the patently absurd declaration that these products are not smokeless tobacco. This let CTP declare these were not subject to their approval process, and therefore they were not obligated to do their job. There has been no expansion of CTP authority since then, and yet here they are ruling on products they declared they had no jurisdiction over. Finally, the SE applications were apparently filed by Star, not the successor company, and FDA sent the full notice of their ruling to Star, not the successor company. Indeed, FDA specifically declared that their ruling forbids Star — who does not now sell these products — from continuing to sell these products. As I said, it is complicated.

What is not complicated is that FDA is clearly using the SE process as a tool of prohibition. The only important SE approvals to date were for non-menthol versions of Lorillard’s flagship cigarettes, a transparent political maneuver. (At the time, CTP still thought they could get away with banning menthol cigarettes. By granting this permission, they would have been able to claim that they were not putting a major corporation out of business with the stroke of a pen.) According to FDA’s public statements, the new dissolvables varieties were rejected because they had higher levels of acetaldehyde and nicotine than the predicate products (which presumably means the original flavors of these products, though even that is not clear).

Acetaldehyde is not good for you, but like most small organic molecules, is a constant exposure among those of us who eat food, and not harmful in reasonable quantities. It is difficult to imagine the quantities in the Ariva/Stonewall variants were enough to pose any real concern (more on that when the rest of us outside the star(!) chamber have a chance to look at the data). I would bet that the difference is far lower than, say, the differences you might find between two apples or two cups of coffee (let alone between those and zero). Basically, if you change the formulation of anything (or nature does it), you will get a little bit less of some chemicals that are bad for you in large doses, and a little bit more of others. This ruling suggests that FDA will use the inevitable latter part of that observation to ban any variation on a product. Note for those who only care about e-cigarettes, this should be seen as the final blow for any hope of being able to exist under the CTP regime (even if there is not an immediate ban of legal sales from the start): If FDA is going to do this for an incredibly well-controlled and clean product like Ariva/Stonewall, there is no hope vaping products will ever get SE approval.

As for the reference to nicotine in the ruling, that speaks even worse of FDA’s games and willingness to disregard science and common sense. Their claim is that a modestly greater quantity of nicotine may make the product more “addictive”. But, of course, tobacco products are not prescription medicines. If you want more nicotine, you buy more. If you want less, you do not use up the entire lozenge (in contrast with many tobacco products, it is pretty easy to set lozenges aside to use later, and people are capable of figuring that out). The nicotine concentration in one sales unit – as with e-cigarettes – hardly matters at all. As for “addiction” and all that, there is no evidence that these slow-delivering, unglamorous products ever “addicted” anyone, and no reason to believe they would. If someone were in pursuit of the rush that can eventually lead to the feeling that is sometimes labeled “addiction”, they would not seek out this product. If it were the only product available and someone wanted to do that, they would probably use two (or three or four) lozenges at once, so the quantity per unit does not matter.

What FDA is clearly doing is trying to impose a creeping prohibition of nicotine, pushing in that direction every time they can. As with creeping shooting wars — in which an administration with no mandate for war, and which would probably face decisive rejection if it asked for it, goes ahead and gets us into the war covertly — creeping prohibitions are unethical and a betrayal of the public trust.

FDA will try to hide behind claims that they are just following the rules. But we and they both know that is a lie. This is a strategic political move, like everything else they do, not a science, law, or health-based decision. It is clear, particularly in light of the active alliance with the mind-controllers at the CDC, that CTP is engaged in social engineering, not regulation. There is nothing in the Tobacco Control Act that suggests that unimportant increases in quantities of unwanted chemicals, let alone nicotine, are a basis for rejecting an SE application. The “S” refers to substantial equivalence, after all, not exact equivalence. No, FDA did this because they wanted to do this. It was a policy choice, not a proper regulatory ruling.

It is difficult to imagine a clearer test of FDA’s intention to use their authority to pursue prohibition, rather than pursuing beneficial regulation or obeying the spirit of the law that Congress thought they were passing. FDA has banned trivial variations on the lowest-risk product out there. (Note: if it turns out we learn that there is so much extra acetaldehyde in these products they can give you a hangover, I will issue a “never mind” — but that is extremely unlikely.) To put it in perspective, if this ruling causes just one would-be user of Ariva Java flavor to keep smoking, it will probably have caused more health risk that of the sum of that caused from every unit of Ariva ever consumed.

Ok, there is one clearer test: how CTP rules on Swedish Match’s MRTP application for their products, which are one step closer to the relevant epidemiology and cannot be rejected on the basis of one chemical. CTP has that chance to show they are honestly pursuing their regulatory mission by approving that application. But I think it is now too late for even that to establish them as ethical and worthy of the public trust. Frankly, unless there is something more to the Ariva/Stonewall ruling than is being reported publicly, I think it is now forever impossible for CTP to claim they are acting as proper regulators or in the interests of the American people.

23 responses to “FDA signals that nothing is ever “substantially equivalent”

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  2. I never believed that any e-cigarette product could gain SE approval, given that it seems there are no known predicate products, i.e., products marketed and sold in the US prior to Feb. 2007. Please correct me if I’m wrong, but I’ve looked hard and can’t find one.

    • Carl V Phillips

      The could not get an initial foothold via SE, no. But once some products were approved, others could be SE to them. Except, apparently (per this post), they can’t.

  3. BAN FOOD and all related FOOD items as they are addictive.(the continued repetition of a behavior despite adverse consequences)

    • Carl V Phillips

      You may have missed this post, including the extensive discussion in the comments https://antithrlies.com/2013/10/07/does-anyone-have-a-valid-definition-of-addiction/ You note one phrase that some people suggest is a definition of addiction. There are many others. My analysis suggests that they all fail. And, yes, for it to succeed, it needs to not describe eating or breathing — that is a good test.

      The relevant point here is that FDA is leaning heavily on a term that they cannot even define, let alone show that the definition applies to the products they are talking about.

  4. Addiction is not the same as dependance….with FOOD it is an addiction and dependance…AIR…Both of those things have Govt controlled substances that in high dosages are LETHAL!!! FOOD AND AIR ARE LETHAL!!!

  5. Norbert Zillatron

    Is anybody surprised?

    It might also be an attempt to create a precedent below the radar.
    Later, wenn some EC manufacturer applies for SE, they pull this out of their hat saying:

    “Sorry, we can’t grant you that. It would be unfair toward Ariva/Stonewall. Those differences were even smaller …”

    Or am I just paranoid by now?
    The voices in my head can’t seem to agree.

    Swedish Match?
    Valiant attempt. Doomed to fail, I assume.

  6. Dr. Phillips,
    From watching the developments of Star Scientific the manufacturing rights were passed to a group of former Star employees who formed Starion to continue making Ariva and Stonewall. Since the original Ariva and Stonewall were offered with confectionery flavors, how can the FDA prohibit the marketing of a product that was on the shelves prior to 2007? The only thing that has changed is the ownership of the rights (or patents, I assume) from Star Scientific to another entity, right?
    Another issue is the mismanagement of the user fees granted the FDA, who’ve used the bulk of the one and half billion collected to air noisome TV ads vilifying the industry that pays them. Another half a billion on dubious research grants and ONLY $25 million to process SE applications. It’s time for the companies that these fees are levied on to fill suit (or an injunction) and withhold payment until the FDA gets their priorities straight. http://www.cspnet.com/category-news/tobacco/articles/gao-reports-fda-user-fee-spending
    Lastly, will Ariva or Stonewall be offered for public sale or is its sale, to the public, stopped by this action of the FDA? At present, the only outlets are through web sites like Northerner.com or sporadic offerings on ebay.

    • Carl V Phillips

      It appears they are only prohibiting new variants (those did change, and Star made the application before selling them off). As I said, I am guessing the predicates they are comparing to are the original versions. Those new variants presumably cannot be sold now by anyone, though strictly speaking FDA only declared that Star could not sell them. I think I mentioned that it is complicated.

      Interesting breakdown from the GAO. It makes it clear that about half of that “user fee” is really being treated as a hidden sales tax. Not cool. I should write a post about that.

      • Hmmm, Dr. Phillips,
        When Ariva was available at our local ‘Kum and Go’ Missouri convenience stores they sold for $2.50 for a 10 piece package. A little over two years ago they disappeared with no explanation from store staff. I called the 1-800 number on the packs and learned it was only available, in my area, by mail order. I’d be interested whether Starion is still able to continue in business but I’ve yet to find a contact point to inquire about the products status.
        As far as the GAO report, I doubt the tobacco companies would have stayed silent as they were had they seen what the user fees were being used for. As it is, the bulk of the money has produced miniscule results as intended. As I said, I’m surprised that the companies, that the user fees are levied, on haven’t filed lawsuits since the FDA has ‘gone off the reservation’ as far as the intent of the tobacco control act of 2009.
        i look forward to the analysis of the GAO report and your take on the FDA monster they’ve grown into. I’m sure that after reviewing all the relevant literature and reflective thought you’ll write a scathing expose on the FDA’s incompetence and malfeasance.

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  9. People don´t smoke for the nicotine. They smoke (and vape) for joy. If they are deprived of nicotine there is a loss of joy and quality of life. And everybody wants a better life. There is no addiction at all … or any improvements of peoples lfes are addictive.

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